The invention generally concerns manual manipulation of a body passage, and more specifically concerns manual manipulation of an upper sphincter of the esophagus of a patient using an implanted device.
Currently, there are few options for persons with life-threatening, profound oropharyngeal dysphagia (OPD). The most common treatment for persons with profound OPD is non-oral, enteral tube feedings, typically administered by a percutaneous enterogastric tube (PEG). Tube feedings, however, do not prevent the aspiration of a patient's own saliva and are associated with severe alterations in an individual's quality of life. Other options for individuals with profound OPD include separating the airway from the swallowing tube as occurs with total laryngectomy and laryngotracheal separation. These operations are associated with significant morbidity and mortality and eliminate an individual's ability for normal voice production and communication. Because they are so morbid and negatively influence an individual's quality of life, they are seldom chosen by patients.
The three primary functions of the larynx are airway protection, respiration, and phonation. If the larynx is unable to provide adequate airway protection during deglutition or if the pharynx is unable to provide adequate bolus transit through the upper esophageal sphincter, OPD ensues. Causes of OPD include stroke, head and neck cancer, head injury, advancing age, cricopharyngeus muscle dysfunction, amyotrophic lateral sclerosis, pseudobulbar palsy, Alzheimer's disease, Parkinson's disease, multiple sclerosis, muscular dystrophy, and myasthenia gravis.
The impact of OPD on quality of life, morbidity, mortality, and health care expenditure is significant. Complications of dysphagia include aspiration, dehydration, pneumonia, malnutrition, depression, and death. Because of the high economic cost of OPD, the significant impact of OPD on quality of life, and the associated morbidity and mortality, improved recognition and treatment of this disorder are warranted. Despite the high prevalence of dysphagia, current treatment options are limited and millions of people remain disabled and feeding tube dependent.